FDA approves Novo Nordisk’s Saxenda for adolescent obesity
pharmafile | December 7, 2020 | News story | Sales and Marketing | FDA, Novo Nordisk, saxenda
The FDA has awarded US approval to Novo Nordisk’s Saxenda (liraglutide) 3mg injection to treat obesity in patients between the ages of 12 and 17.
According to the approval, the drug is to be recommended alongside physical activity and a reduced-calorie diet in patients weighing at least 60 kg with a body mass index (BMI) corresponding to 30 kg/m2 or more. Prevalence of overweight children and adolescent patients around the world has doubled in the last 20 years.
Phase 3 data published earlier in the year in the New England Journal of Medicine demonstrated that Novo’s drug, when offered alongside nutrition counselling and physical activity, generated a significant reduction in Body Mass Index (BMI) Standard Deviation Score (SDS) after 56 weeks compared to placebo, meeting the study’s primary goal.
Additionally, Saxenda also successfully reduced BMI, average body weight, and other weight-related metrics over placebo.
“New options to treat adolescents who live with obesity can bring much needed hope to families and help address this growing epidemic,” explained Dr Aaron Kelly, Professor of Pediatrics and co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota. “With up to 90% of adolescents with obesity likely to have it as adults and thus at increased risk for developing weight-related complications, it’s important to address weight care and offer support early on. I’m encouraged that healthcare providers now have another tool in developing a personalised, complete care plan to help adolescents lose weight and keep it off.”
Matt Fellows
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